The Effect of Epidural Steroid Use in Patients With Continous Epidural Block in PHN Patients.

June 21, 2019 updated by: Jung Eun Kim, Korea University Guro Hospital

The Effect of Epidural Steroid Use on Pain Relief in Patients With Continuous Epidural Nerve Block in Postherpetic Neuralgia Patients.

The efficiency of epidural steroid injection in patients who has postherpetic neuralgia is well known. In this study, the purpose is whether the continous epidural steroid injection is effective or not.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Continous epidural injection will be done during 10 days. D group will be injected a 0.19% ropivacaine 8mL and dexametasone 1mg every other day during 10 days.

Continous epidural injection will be done during 10 days N group will be injected a 0.19% ropivacaine 8mL only every other day during 10 days

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Yeongdeungpo-gu
      • Seoul, Yeongdeungpo-gu, Korea, Republic of, 07441
        • Recruiting
        • KangNam Sacred Heart Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who has herpes zoster
  • Patients has a period (at least 1month) after onset of herpes zoster
  • Patients has a definite symptom along dermatome
  • ASA class I - II
  • Age : 18 - 80 years

Exclusion Criteria:

  • Patients who has a cancer
  • Patients who has a neurologic, psychologic, renal, hepatic and hematologic disease
  • Patients who has a other dermatologic disease
  • Patients who has major operation & procedure history
  • Patients who has a other pain origin
  • Patients who can not be inserted epidural catheter

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: D group
0.19% Ropivacaine 8mL + Dexametasone 1mg every other day injection during 10 days
Drug: Dexamethasone

Continous epidural injection will be done during 10 days. D group will be injected a 0.19% ropivacaine 8mL and dexametasone 1mg every other day during 10 days.

.

Other Names:
  • DEXA-S
Drug: Ropivacaine
Continous epidural injection will be done during 10 days Both group will be injected a 0.19% ropivacaine 8mL every other day during 10 days
Other Names:
  • Rocaine
Placebo Comparator: N group
0.19% Ropivacaine 8mL only every other day injection during 10 days
Drug: Ropivacaine
Continous epidural injection will be done during 10 days Both group will be injected a 0.19% ropivacaine 8mL every other day during 10 days
Other Names:
  • Rocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS score
Time Frame: up to 10 days
The investigator set the primary outcome If there is a 50% reduction of VAS score.
up to 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Guro Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2019

Primary Completion (Anticipated)

May 30, 2020

Study Completion (Anticipated)

November 30, 2020

Study Registration Dates

First Submitted

June 21, 2019

First Submitted That Met QC Criteria

June 21, 2019

First Posted (Actual)

June 24, 2019

Study Record Updates

Last Update Posted (Actual)

June 24, 2019

Last Update Submitted That Met QC Criteria

June 21, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-04-011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

IPD sharing is not decided.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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